FDA Medical Device Recalls (openFDA)
Peter Lazic Gmbh: L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile
- Recall number
- Z-1288-2024
- Recalling firm
- Peter Lazic Gmbh
- Product
- L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile
- Status
- Open, Classified
- Initiated
- 2023-07-14
- Posted
- 2024-03-12
- Terminated
- not on file
- Reason
- Wrong product coloring. The paddle clips should be blank, but they are colored blue.
- Root cause
- Process control
- Action
- Scripted Phone calls were made to customers on July 14, 2023. The customers were provided information on how to identify affected product and to return all product subject to recall and to notify any of their customers as well. Instructions for return were provided. Updated 3/11/24: Customer notification letters sent out on March 5, 2024 to summarize the information from the phone calls. Customers were instructed to inspect their inventory and return all stock products to one of the PRRCs (info@lazic.de/+49 (0) 7461 96643-20 or k.maier@lazic.de/+49 (0) 7461 96643-21).
- Quantity
- 51 units
- Distribution
- US Nationwide distribution in the state of ME.
- Lot, serial or model codes
- Model Number: 45.782; UDI/DI: 04250603733799; Serial Numbers: LX61385, LW36020, LW36021, LW36022, LW36023, LW36024, LW36025, LW36026, LW36027;
- 510(k) numbers
- ["K081489"]
- PMA numbers
- not on file
- Product code
- HCH
- Firm FEI
- 3007264034
- Firm city
- Tuttlingen
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28